INTRODUCTION
Good morning, Mr. Chairman and Members of the Subcommittee. My name is Dr.
Thomas Shope. I am the Acting Director, Division of Electronics and Computer
Science, Office of Science and Technology, Center for Devices and Radiological
Health (CDRH), Food and Drug Administration (FDA). I am pleased to be here to
provide information about the "Year 2000" date issue as it relates to medical
devices.
WHAT IS A MEDICAL DEVICE?
According to the definition in the Federal Food, Drug, and Cosmetic Act
(FD&C; Act), a "device" is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part or
accessory, which is intended, for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals, or intended to affect the structure or any function of the
body and. which does not achieve its primary intended purposes through chemical
action and which is not dependent upon being metabolized for the achievement of
its primary intended purposes.
As this definition suggests, many different types of products are properly
regulated as medical devices. Medical devices include over 100,000 products in
more than 1,700 categories. These products regulated by FDA as medical devices
range from simple everyday articles such as thermometers, tongue depressors, and
heating pads, to the more complex devices such as pacemakers, intrauterine
devices, fetal stents and kidney dialysis machines.
FDA is responsible for protecting public health by helping to ensure that
medical devices are safe and effective. FDA carries out its mission by
evaluating new products before they are marketed; assuring quality control in
manufacture through inspection and enforcement activities; and monitoring
adverse events in already marketed products, taking action, when necessary, to
prevent injury or death. A device manufacturer must comply with all the
requirements of the FD&C; Act, including: establishment registration and device
listing, pre-market review, use of good manufacturing practices (GMPs),
reporting adverse events, and others.
As diverse as medical devices are, so are the range and complexity of
problems that can arise from their use. These problems include mechanical
failure, faulty design, poor manufacturing quality, adverse effects of materials
implanted in the body, improper maintenance/specifications, user error,
compromised sterility/shelf life and electromagnetic interference among devices.
Any computer software that meets the legal definition of a medical device is
subject to applicable FDA medical device regulations. Medical devices which use
computers or software can take several forms including: embedded microchips
which are part of, or components of, devices; or non-embedded software used
with, or to control, devices or record data from devices; or individual software
programs which use or process patient data to reach a diagnosis, aid in therapy
or track donors and products.
An issue that has been identified as warranting review is the impact of the
"Year 200011 on some medical device computer systems and software applications.
These products could be impacted by the "Year 200011 date problem only if they
use a date in their algorithm or calculations, or in record keeping; and a
two-digit year format was used in their design. Manufacturers of such products
are the only reliable source of information as to the details of the methods
used in the programming and whether these two conditions are met. While we are
in the process of reviewing this issue, we do not currently believe that there
will be any major impact on medical device safety.
Embedded Software
Computer software frequently is embedded as a "component" of devices, i.e.,
software contained on a microchip to control device operation. Examples of such
devices are: pacemakers, infusion pumps, ventilators, and many others. It is
unlikely that most of these products would be impacted by the "Year 2000"
problem. Almost none of these devices require knowledge of the current date to
operate safely and effectively. For example, pacemakers do not use the current
date in their operation.
Non-embedded software
Non-embedded software is intended to be operated on a separate computer,
often a personal computer or work station. Such software devices may be used to
enhance the operation of another device or devices and, further, may use the
two-digit year format. It is possible that non-embedded software devices may
rely on the current date for proper operation and, further, may use the
two-digit year format. Such products might be affected by the "Year 2000" date
change.
An example of non-embedded software is a computer program used to plan
radiation therapy treatments delivered using radioactive isotopes as the
radiation source (teletherapy or brachytherapy). These treatments possibly could
be affected if the computer program used to calculate the radiation dose
parameters uses only a two-digit year representation. The calculation of the
length of time since the source was last calibrated could be in error and thus
lead to an incorrect treatment prescription.
Other examples of non-embedded software devices include: conversion of
pacemaker telemetry data; conversion, transmission or storage of medical images;
off-line analysis of EEG data; digital analysis and graphical presentation of
EEG data; calculation of rate response for a cardiac pacemaker; perfusion
calculations for cardiopulmonary bypass; and calculation of bone fracture risk
from bone densitometry data. While there is a chance that the two-digit format
may affect the performance of these software devices, we believe that the "Year
2000" risk will be mitigated through proactively working with manufacturers.
Device Manufacturers
In light of our review of the impact of the "Year 2000" on some medical
device computer systems and software applications, CDRH is preparing to send a
letter to all medical device manufacturers to ensure that manufacturers address
this issue and review both embedded and non-embedded software products. We will
remind manufacturers that, in addition to potentially affecting the functioning
of some devices, the two-digit year format also could affect computer-controlled
design, production or quality control. processes. We will request that the
manufacturers review the' software used to determine if there is any risk.
CDRH will recommend specific actions to ensure the continued safety and
effectiveness of these devices. For currently manufactured medical devices,
manufacturers should conduct hazard and safety analyses to determine whether
device performance could be affected by the "Year 200011 date change. If these
analyses show that device safety or effectiveness could be affected, then
appropriate steps should be taken to correct current production and to assist
customers who have purchased such devices. For computer-controlled design,
production and quality control processes, manufacturers should assure that
two-digit date formats or-computations do not cause problems beginning January
1, 2000.
In our letter to industry, we will remind manufacturers that under the GMP
regulation and the current Quality System Regulation (which became effective
June 1, and incorporates a set of checks and balances in manufacturers' design
processes to assure a safe, effective finished product), they must investigate
and correct problems with medical devices that present a significant risk to
public health. This includes devices that fail to operate according to their
specifications because of inaccurate date recording and/or calculations.
As a result of our letter, we expect manufacturers who identify products
which have a date-related problem which can pose a significant risk to the
patient to take the necessary action to remedy the problem. This might include
notification of device purchasers so that their device can be appropriately
modified before the "Year 2000.11 Manufacturers who discover a significant risk
presented by a date problem are required to notify CDRH and take appropriate
action. Again, we do not anticipate any significant problems with individual
medical devices, however, we want to ensure the continued safety and
effectiveness of these devices.
For future medical device pre-market submissions, manufacturers of devices
whose safe operation could be affected by the "Year 2000" date change will be
required to demonstrate that the products can perform date recording and
computations properly, i.e., 'Year 200011 compliant.
CONCLUSION
Thank you, Mr. Chairman, for the opportunity to tell you about the issue of
"Year 2000" and medical devices. Let me assure you, we at FDA take this issue
very seriously as we do all problems that could affect the public health. We are
committed to a scientifically sound regulatory environment that will provide
Americans with the best medical care. In the public interest, FDA's commitment
to industry must be coupled with a reciprocal commitment: that medical device
firms will meet high standards in the design, manufacture, and evaluation of
their products. We recognize that this can only be attained through a
collaborative effort between FDA and industry -- grounded in mutual respect and
responsibility. The protections afforded the American consumer, and the benefits
provided the medical device industry, cannot be underestimated.
